Cleared Traditional

K854196 - DCI MODEL EP-2 CLINICAL STIMULATOR

K854196 is an FDA 510(k) clearance for DCI MODEL EP-2 CLINICAL STIMULATOR, manufactured by Digital Cardiovascular Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K854196 · Digital Cardiovascular Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
198d
Days
Class 2
Risk

K854196 is an FDA 510(k) clearance for the DCI MODEL EP-2 CLINICAL STIMULATOR. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Digital Cardiovascular Instruments, Inc. (Emeryville, US). The FDA issued a Cleared decision on May 1, 1986 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Digital Cardiovascular Instruments, Inc. devices

FDA 510(k) Submission Details - K854196

510(k) Number K854196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date May 01, 1986
Days to Decision 198 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 57
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K854196.
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
K871569 · Cardiac Resucitator Corp. · Jun 1987
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
K863547 · Medtronic Vascular · Oct 1986
ALTERNATE SIZE E-Z-PACE ELECTRODE
K862298 · Medtronic Vascular · Jul 1986
AMI CARDIO-PAD
K860283 · Andover Medical, Inc. · Mar 1986
AMENDMENT LIFEPAK 8, NPN 052
K854117 · Physio-Control Corp. · Jan 1986
LIFEPAK 8 MODIFICATION
K853732 · Physio-Control Corp. · Dec 1985